Advance Radioactive-Iodine Refractory Differentiated Thyroid Cancer
Conditions
Brief summary
The primary endpoint for this biomarker-focused trial is the determination of cfCHIP-seq on isolated chromatin nucleosomes from blood samples extracted to patients with DTC at baseline, before any dose of study treatment, after 24 weeks of treatment, at the end of treatment, at the beginning of new line of treatment if started >3 months after the end of treatment.
Detailed description
The molecular biomarkers at baseline will be crossed with the following endpoints to find potential prognostic value for cabozantinib efficacy: ● Disease control rate (DCR) ● Duration of Response (DoR) ● Progression-free Survival (PFS) ● Overall Survival (OS), The molecular biomarkers at baseline will be crossed with the following endpoints to find potential prognostic value for cabozantinib safety: Frequency and severity of adverse events and Treatment-related adverse events (TRAEs) assessed by NCI CTCAE v5.0. Frequency of AEs leading to treatment discontinuation. Health-related quality of life (HRQoL), assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) version 3
Interventions
Sponsors
Grupo Espanol De Tumores Neuroendocrinos
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this biomarker-focused trial is the determination of cfCHIP-seq on isolated chromatin nucleosomes from blood samples extracted to patients with DTC at baseline, before any dose of study treatment, after 24 weeks of treatment, at the end of treatment, at the beginning of new line of treatment if started >3 months after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The molecular biomarkers at baseline will be crossed with the following endpoints to find potential prognostic value for cabozantinib efficacy: ● Disease control rate (DCR) ● Duration of Response (DoR) ● Progression-free Survival (PFS) ● Overall Survival (OS), The molecular biomarkers at baseline will be crossed with the following endpoints to find potential prognostic value for cabozantinib safety: Frequency and severity of adverse events and Treatment-related adverse events (TRAEs) assessed by NCI CTCAE v5.0. Frequency of AEs leading to treatment discontinuation. Health-related quality of life (HRQoL), assessed through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) version 3 | — |
Countries
Spain
Outcome results
None listed